• Designation confers advantages including marketing exclusivity and tax credits 
• Padeliporfin VTP Phase 1 trial in Pancreatic cancer to start by end Q4 2023

The Investigational New Drug (IND) application, allowing initiation of the Phase 1 clinical trial of Padeliporfin VTP in patients with locally advanced pancreatic ductal adenocarcinoma, will be submitted later this year and is expected to begin enrollment this year. Padeliporfin VTP has also previously received Fast Track designation and Orphan Drug Designation from the FDA for the treatment of adult patients with low-grade UTUC.

Orphan drug status confers a number of advantages for product development, including a tax credit for the cost of clinical trials undertaken in the US, marketing exclusivity for seven years, written recommendations from the FDA on clinical and preclinical studies needed for approval and a fast-track procedure for regulatory review.

Barak Palatchi, CEO of ImPact Biotech, said, “We are delighted to receive Orphan Drug Designation for Padeliporfin VTP in Pancreatic Cancer, further validating ImPact’s technology and the potential benefits our product could bring to patients with locally advanced Pancreatic Cancer. We continue to believe and follow our strategy, refocusing Padeliporfin VTP treatment on patients with limited treatment options. In Pancreatic Cancer, with limited treatment options for patients who have unresectable locally advanced disease our hope is that Padeliporfin VTP will offer a safe and effective treatment that will render the disease eligible for definitive treatment. Pancreatic Cancer is one of our priority indications within our ambitious plan. We are looking forward to exploring the possibility of offering Padeliporfin VTP to more patients coping with life threatening cancers.”

ImPact Biotech is focusing on the development of Padeliporfin VTP as a minimally invasive oncology platform for the treatment of solid tumors, with the potential to offer surgery-like efficacy, combined with healthy-tissue or organ preservation in solid tumors for high-risk surgical patients with unmet needs – either because surgery is not the preferred clinical option, or the risk of surgery is too high.